BEUDAMED
    FDA Registration Active 🇨🇳 China

    ZUMAX MEDICAL CO, LTD.

    Reg #: 3006252153 · FEI: 3006252153 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    114
    Establishment Types
    3
    Classifications
    19

    Registration Details

    Registration Name
    ZUMAX MEDICAL CO, LTD.
    Registration Number
    3006252153
    FEI Number
    3006252153
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5 ZHIYING STREET, SUZHOU NEW DISTRICT
    City
    SUZHOU,JIANGSU
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K141392

    Owner / Operator

    Firm Name
    ZUMAX MEDICAL CO, LTD.
    Operator Number
    9093892
    Address
    5 ZHIYING STREET, SUZHOU NEW DISTRICT
    City
    SUZHOU
    State
    Jiangsu
    Postal Code
    215129
    Country
    CN
    Correspondent
    XIANGDONG - LI

    US Agent

    Business Name
    Zumax USA, Inc.
    Contact Name
    Grace Wei
    Address
    8 The Green #20218, Dover, DE 19901
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    651 3003907

    Products

    Device Name Product Code
    Unit, Suction Operatory EBR
    Ophthalmoscope, Ac-Powered HLI
    Colposcope (And Colpomicroscope), Exempt PTZ
    Retinoscope, Battery-Powered HKM
    Transilluminator, Battery-Powered HJN
    Light, Examination, Medical, Battery Powered KYT
    Ophthalmoscope, Battery-Powered HLJ
    Biomicroscope, Slit-Lamp, Ac-Powered, Exempt PUE
    Device, Medical Examination, Ac Powered KZF
    Speculum, Ent EPY
    Loupe, Binocular, Low Power HJH
    Instrument, Hand, Calculus Removal ELA
    Light, Surgical Headlight EBA
    Retinoscope, Ac-Powered HKL
    Instrument, Microsurgical GZX
    Otoscope ERA
    Microscope, Operating & Accessories, Ac-Powered, Ophthalmic HRM
    Blood Pressure Cuff DXQ
    Microscope, Surgical, General & Plastic Surgery FSO

    Proprietary Names

    DSD-01 Dental Suction Unit DM6F Ophthalmoscope DM6GP Ophthalmoscope DM6G Ophthalmoscope DM6FP Ophthalmoscope DW3010 DW1050 DW1100 DW1000 DW3060 DW2010 DW1060 CLS3080 Colposcope SR24B STREAK RETINOSCOPES SR24A STREAK RETINOSCOPES DW3050 SR24 STREAK RETINOSCOPES GL50 Series Illuminator 472E0010 GL60 Series Illuminator 485 0010 4057850 411E0010 405E7850 4677860 490-0015 DM6UEP 4110010 487 1000 488 1000 DM6DP DM6U DM6UE 410E0010 410-0010 DW2000 DM6UP DM6C 467E7860 DM6DEP DM6D DM6BE DW3000 489 0010 DM6BEP DM6DE DM6CE BM800 Binocular Indirect Ophthalmoscope SL200 Handheld slit lamp SL260 slit lamp VARIOUS MODELS BINOCULAR LOUPES SLT Binocular Loupes SLE Binocular Loupes SLH Binocular Loupes SLF Binocular Loupes SLD Binocular Loupes SLS Binocular Loupes DFK Binocular Loupes DFK air Binocular Loupes DFT Binocular Loupes SLK Binocular Loupes Broken Instrument Removal Kit HL8300 HEADLIGHT HL8000 HEADLIGHT HL8200 HEADLIGHT HL8350 HEADLIGHT HL8260 HEADLIGHT HEADLIGHTS SR24F Streak Retinoscope SR24G Streak Retinoscope Micro Tweezers Micro Scissors Micro Needle Holder Forceps OTOSCOPE OT8 series otoscopes OT8V OT8FS OT8H OT8G OT8DS OT8D OT8F OT8C OT8K OT8GS OMS2680 ophthalmic microscope OMS2650 ophthalmic microscope 485-0081 SM620 SM630 485-0625 485-0080 485-0630 OMS2300 surgical microscope OMS2350 surgical microscope OMS2380 surgical microscope OMS3200 surgical microscope OMS1950 surgical microscope OMS2365 surgical microscope OMS2360 surgical microscope OMS2650 surgical microscope OMS2355 surgical microscope OMS3200Pro surgical microscope OMS2030 surgical microscope OMS3500 surgical microscope OMS2000 surgical microscope OMS3300 surgical microscope OMS3000 surgical microscope OMS2050 surgical microscope OMS1800 surgical microscope OMS2680 surgical microscope OMS3500 Max surgical microscope OMS6000 surgical microscope OMS3000 Pro surgical microscope

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)